I-STAT B-HCG CARTRIDGE 05P58-25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for I-STAT B-HCG CARTRIDGE 05P58-25 manufactured by Abbott Point Of Care.

Event Text Entries

[32032725] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[32032726] On (b)(6) /2015, abbott point of care was contacted by a customer regarding i-stat b-hcg cartridges that yielded a suspected false positive result of 30. 9 on a (b)(6) year old female patient. The test was repeated on an alternate method and the result was 0. 0 based on the information available. The customer states that the patient was also tested using the quickvue serum/urine kit and was negative. The b-hcg test was done as pre-op testing for a tonsillectomy. The customer states that the procedure was completed. Date: method: result: (b)(6) 2015, i-stat, 30. 9. (b)(6) 2015, dimension exl, 0. 0. (b)(6) 2015, quickvue serum/urine kit, negative. There was no repeat on the i-stat and at this time there is no reason to suspect that a malfunction exists. Based on the information available and internal control algorithms the event is reportable as a potential product malfunction although not confirmed at this time. There are no injuries associated with this event. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5


[33303784] (b)(4). The investigation was completed on (b)(4) 2015. Retain product was tested and is functioning according to specification. Return product was not available for investigation.
Patient Sequence No: 1, Text Type: N, H10


[33303785]
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2245578-2015-00065
MDR Report Key5240566
Date Received2015-11-20
Date of Report2015-12-11
Date of Event2015-11-06
Date Mfgr Received2015-12-02
Device Manufacturer Date2015-08-28
Date Added to Maude2015-11-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLINDA MACZUSZENKO
Manufacturer Street400 COLLEGE ROAD
Manufacturer CityPRINCETON NJ 08540
Manufacturer CountryUS
Manufacturer Postal08540
Manufacturer Phone6136885949
Manufacturer G1ABBOTT POINT OF CARE CANADA LTD.
Manufacturer Street185 CORKSTOWN ROAD
Manufacturer CityOTTAWA, ONTARIO K2H 8V4
Manufacturer CountryCA
Manufacturer Postal CodeK2H 8V4
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameI-STAT B-HCG CARTRIDGE
Generic NameB-HCG CARTRIDGE
Product CodeNAL
Date Received2015-11-20
Model NumberNA
Catalog Number05P58-25
Lot NumberA15240
Device Expiration Date2016-01-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABBOTT POINT OF CARE
Manufacturer Address400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-20

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